A Prospective, Single-Center, Observational Cohort Study to Evaluate the Short-Term and Long-Term (2-Year) Effects of Laparoscopic Splenectomy on Renal Function in Patients With Liver Cirrhosis, Splenomegaly and Hypersplenism
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Serum creatinine (Scr) level
研究概览
简要总结
Patients with liver cirrhosis often have impaired or at-risk kidney function due to the close link between liver and kidney (hepatorenal syndrome). Laparoscopic splenectomy is commonly used to treat splenomegaly and hypersplenism in these patients, but its impact on kidney function over 2 years is unclear. This study will follow patients undergoing laparoscopic splenectomy to measure changes in kidney function before and after surgery, identify risk factors for kidney damage and whether laparoscopic splenectomy can improve kidney function in the long term, and help improve care to protect kidney function in cirrhotic patients .
详细描述
Rationale: Liver cirrhosis is associated with systemic hemodynamic disturbances, reduced effective circulating volume, and renal hypoperfusion, creating a high risk of renal dysfunction and hepatorenal syndrome (HRS)-a life-threatening condition reflecting the critical hepatorenal interaction. Patients with cirrhosis, splenomegaly and hypersplenism frequently have subclinical or overt renal impairment preoperatively. Laparoscopic splenectomy (LS) is a standard intervention for hypersplenism, but perioperative stress, hemodynamic fluctuations, and surgical trauma may further compromise renal function and laparoscopic splenectomy may improve the kidney function in the long term. Current evidence lacks prospective, 2-year data on renal function changes after LS in this high-risk population, especially regarding the hepatorenal axis and long-term renal outcomes. This study aims to fill this gap to guide perioperative renal protection strategies.
Study Design: Prospective, single-center, observational cohort study with a total duration of 24 months (2 years). Patients with cirrhosis, splenomegaly and hypersplenism scheduled for elective laparoscopic splenectomy will be enrolled and followed for 2 years to assess renal function dynamics and identify risk factors for renal injury .
Study Timeline:
- Months 1-6: Patient screening, enrollment, baseline assessment
- Months 1-18: Laparoscopic splenectomy and perioperative short-term renal function monitoring
- Months 7-24: Long-term follow-up at 3, 6, 12, 24 months postoperatively
- Month 24: Data analysis and study completion
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of liver cirrhosis (clinical, laboratory, imaging)
- •Splenomegaly and hypersplenism
- •No history of portal hypertension bleeding (esophageal and gastric variceal bleeding )
- •Age 18-80 years, male or female
- •Child-Pugh Class A or B liver function
- •No history of primary renal disease or acute kidney injury (AKI)
- •Signed written informed consent
- •Ability to complete 24-month follow-up
排除标准
- •Child-Pugh Class C liver cirrhosis
- •Primary renal diseases (glomerulonephritis, polycystic kidney disease, chronic pyelonephritis, etc.)
- •Previous abdominal surgery precluding safe laparoscopic splenectomy
- •Severe cardiac, pulmonary, cerebrovascular dysfunction; malignant tumors; primary hematological disorders
- •Cirrhotic complications (portal hypertension bleeding, hepatic encephalopathy, refractory ascites) within 1 month before surgery
- •Pregnancy or lactation
- •Poor compliance, inability to complete follow-up
结局指标
主要结局
Serum creatinine (Scr) level
时间窗: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Change in serum creatinine (Scr) level
Glomerular filtration rate (eGFR)
时间窗: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Change in estimated glomerular filtration rate (eGFR) For females: If serum creatinine (Scr) ≤ 0.7 mg/dL: eGFR = 142 × (Scr/0.7)\^(-0.241) × (0.9938)\^Age; If Scr \> 0.7 mg/dL: eGFR = 142 × (Scr/0.7)\^(-1.200) × (0.9938)\^Age. For males: If Scr ≤ 0.9 mg/dL: eGFR = 142 × (Scr/0.9)\^(-0.302) × (0.9938)\^Age; If Scr \> 0.9 mg/dL: eGFR = 142 × (Scr/0.9)\^(-1.200) × (0.9938)\^Age. Note: Results are in mL/min/1.73 m². Age is in years.
次要结局
- BUN and UA level(at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24)
- Urine albumin-to-creatinine ratio (UACR)(at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24)
- Intraoperative variables(During the procedure of operation)
- Postoperative complications(at preoperative baseline, postoperative day 1, day 3, day 7, month 1, month 3, month 6, month 12, month 18, month 24)
- Child-Pugh grade(at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24)
- Albumin and bilirubin level(at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24)
研究者
Guo-Qing Jiang
Clinical Professor
Northern Jiangsu People's Hospital